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Steady_T

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Re: Joseph_K post# 444190

Tuesday, 12/26/2023 4:45:13 PM

Tuesday, December 26, 2023 4:45:13 PM

Post# of 462177
Hmmm. The key phrase is "Notify EMA of the intended submission date (letter of intent)"
The letter of intent starts the 7 months clock.

Submission of the eligibility request can occur 18 to 7 months before MAA submission.
I went back and looked at the PR and it talks about approval for Centralized Marketing application.

I can't find anything specific about a letter of intent in the PR or the CC.

Bottom line is you are probably correct.

"Wise men talk because they have something to say, fools because they have to say something."
PLATO

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